THOUSAND OAKS, Calif.,
July 20, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for review the
Biologics License Application (BLA) for Aimovig™ (erenumab) for the
prevention of migraine in patients experiencing four or more
migraine days per month. If approved, Aimovig is expected to be the
first-and-only monoclonal antibody targeting the calcitonin
gene-related peptide (CGRP) receptor, specifically designed for the
prevention of migraine.
"Migraine is a serious neurological disease that has a
substantial economic burden for both patients and the healthcare
system, yet it continues to be under recognized and under treated,"
said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "We are
pleased to advance Aimovig, our migraine-specific preventive
therapy, to help address the unmet need in this community and
potentially mitigate the overall burden of this disease for
patients who have already tried other therapeutic options."
The BLA for Aimovig includes data from pivotal studies of more
than 2,600 patients experiencing four or more days of migraine per
month. Phase 2 and Phase 3 clinical studies of Aimovig versus
placebo have demonstrated a reduction in the number of
migraine-affected days, disability and acute medication use for
patients with episodic and chronic migraine. The safety profile of
Aimovig was similar to placebo across all treatment arms in the
Phase 2 and Phase 3 studies for up to six months. The most common
adverse events across the studies were upper respiratory tract
infection, injection site pain, nausea and nasopharyngitis.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target
action date of May 17, 2018.
Aimovig will be jointly commercialized in the U.S. by Amgen and
Novartis.
About Aimovig™ (erenumab)
Aimovig is the only
fully human monoclonal antibody specifically designed for the
prevention of migraine that has been filed with the FDA. Aimovig
specifically inhibits the receptor of the calcitonin gene-related
peptide (CGRP), which is thought to play a causal role in migraine
pathophysiology. Aimovig has been studied in several large global,
randomized, double-blind, placebo-controlled trials to assess its
safety and efficacy in migraine prevention.
About Migraine
Migraine is a distinct neurological
disease.3 People with migraine lose a substantial
portion of their lives to this illness, experiencing significant
physical impairment, frequently accompanied by head pain, nausea,
vomiting and meaningful disruption of daily activities.3
The World Health Organization ranks migraine as one of the most
debilitating illnesses.4 For the approximately 10
million Americans whose migraine frequency or severity impacts
daily activities, preventive medications may be an
option.5 Approximately 3.5 million of these patients are
currently on a preventive therapy, but up to 80 percent discontinue
these within one year.5,6 Migraine is associated with
personal and societal burdens of pain, disability, and financial
cost, and it remains under recognized and under treated.
About Amgen and Novartis Neuroscience Collaboration
In
August 2015, Amgen entered into a
global collaboration with Novartis to jointly develop and
commercialize pioneering treatments in the field of migraine and
Alzheimer's disease (AD). The collaboration focuses on
investigational Amgen drugs in the migraine field, including
Aimovig (BLA accepted by the FDA in July
2017) and AMG 301 (currently in Phase 1 development). In
April 2017, the collaboration was
expanded to include co-commercialization of Aimovig in the U.S. For
the migraine program, Amgen retains exclusive rights in
Japan, and Novartis has exclusive
rights in Europe, Canada and rest of world. Also, the companies
are collaborating in the development and commercialization of a
beta-secretase 1 (BACE) inhibitor program in AD. The oral therapy
CNP520 (currently in Phase 3 for AD) is the lead molecule and
further compounds from both companies' pre-clinical BACE inhibitor
programs may be considered as follow-on molecules.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us
on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen
is providing this information as of the date of this news release
and does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new
information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints we have selected. We develop
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as we may
have believed at the time of entering into such relationship. Also,
we or others could identify safety, side effects or manufacturing
problems with our products after they are on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. We or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations,
litigation and product liability claims. In addition, our business
may be impacted by the adoption of new tax legislation or exposure
to additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
and also depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. Certain of our distributors, customers and payers have
substantial purchasing leverage in their dealings with us. The
discovery of significant problems with a product similar to one of
our products that implicate an entire class of products could have
a material adverse effect on sales of the affected products and on
our business and results of operations. Our efforts to acquire
other companies or products and to integrate the operations of
companies we have acquired may not be successful. We may not be
able to access the capital and credit markets on terms that are
favorable to us, or at all. We are increasingly dependent on
information technology systems, infrastructure and data security.
Our stock price is volatile and may be affected by a number of
events. Our business performance could affect or limit the ability
of our Board of Directors to declare a dividend or our ability to
pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by the U.S.
Food and Drug Administration for the products. The products are not
approved for the investigational use(s) discussed in this news
release, and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for these uses.
*The trade name Aimovig™ is provisionally approved for use by
the U.S. Food and Drug Administration.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References
1 American Migraine Foundation.
The Burden of Migraine.
https://americanmigrainefoundation.org/living-with-migraines/.
Accessed July 11, 2017.
2 Hawkins K, Wang S, Rupnow M. Direct cost burden among
insured US employees with migraine.
Headache. 2008;48(4):553-563.
3 Lipton RB, et al. Migraine prevalence, disease burden,
and the need for preventative therapy. Neurology. 2007;
68(5):343-9.
4 Headache disorders - Fact sheets. World Health
Organization. http://www.who.int/mediacentre/factsheets/fs277/en/.
Accessed March 3, 2017.
5 Marketscan data on file. March
31, 2017. Ref Type: Data File
6 Hepp Z et al. Adherence to oral migraine-preventive
medications among patients with chronic migraine. Cephalalgia.
2015; 35(6):478-88.
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SOURCE Amgen